SoniVie Reports Major Advancements in Renal Denervation Program for Hypertension: REDUCED-1 Results, First-In-Human Data, FDA’s Crucial IDE Approval of Global THRIVE study

SoniVie has announced major advancements in its renal denervation program. At the EuroPCR conference, the company revealed promising results from the REDUCED-1 Pilot study, demonstrating a significant reduction in daytime ambulatory systolic blood pressure. The study highlighted that a substantial portion of participants responded positively. Importantly, no device-related adverse events were reported, and efficacy remained consistent at follow-up. Additionally, the first-in-human case using the 4Fr Rapid Exchange Radial Access TIVUS Catheter was presented. Recently, the FDA approved the Investigational Device Exemption (IDE) THRIVE study, which aims to assess the TIVUS System’s safety and effectiveness in hypertensive patients. The study will involve international sites and is led by a distinguished Global Steering Committee. Consequently, SoniVie prepares to enroll the first patient later this year.

Promising Results from REDUCED-1 Pilot Study

SoniVie, a developer of the novel Therapeutic Intra-Vascular Ultrasound System (TIVUS™), presented significant findings at the EuroPCR conference in Paris on May 15, 2024. Dr. James Zidar from the University of North Carolina presented the 3-month primary efficacy data from the REDUCED-1 Pilot study, which involved 40 patients (25 in the US and 15 in Israel). Here, the study showed an average reduction of 12.0 mmHg in daytime ambulatory systolic blood pressure (ASBP) from baseline to 3 months, with 78.4% patients being responders (≥5mm reduction in daytime ASBP). The responder group saw an average reduction of 16.2 mmHg in ASBP at 3 months.

Notably, the study reported no device-related adverse events in the 1-month primary safety endpoint analysis. Additionally, the efficacy data remained consistent at the 6-month follow-up. This marks the first use of a no-touch renal denervation (RDN) device that does not need to contact the renal artery vessel wall, setting it apart from previous RDN technologies.

First-In-Human Treatment and FDA Approval for THRIVE Study

Professor Michael Jonas from Kaplan, Israel, presented the first-in-human clinical case using the 4Fr Rapid Exchange Radial Access TIVUS Catheter, representing a significant evolution in RDN technologies. Additionally, on July 17, 2024, the FDA approved the THRIVE study, an international, multicenter, randomized, double-blind, sham-controlled trial. This study aims to demonstrate the effectiveness and safety of the TIVUS System in hypertensive patients. Participants will first be off antihypertensive medications for a 4-week wash-out period before the RDN/Sham procedure and will remain off medication for 2 months after.

After 2 months, subjects with uncontrolled hypertension will resume antihypertensive medication according to a medication escalation protocol. Furthermore, unblinding will occur at 6 months, with sham-controlled subjects having the option to crossover to TIVUS. The THRIVE Study is led by a Global Steering Committee that includes Dr. Ajay Kirtane from Columbia University Medical Center in New York City, Dr. Michel Azizi from George Pompidou Hospital in Paris, and Dr. Felix Mahfoud from the University of Basel in Switzerland.

Global Efforts and TIVUS Technology

Tomaso Zambelli, Chief Executive Officer of SoniVie, noted that the company’s clinical operations teams in the US, Europe, and Israel are supporting sites, physicians, and patients participating in the THRIVE Study. They anticipate enrolling the first patient in the fourth quarter of 2024. Renal denervation with TIVUS employs a minimally invasive approach using a high-frequency, non-focused ultrasound energy catheter. Specifically, this device does not anchor to the vessel wall during treatment. Instead, it ablates nerves in the tissue surrounding the renal arteries, which reduces sympathetic activity and lowers blood pressure.

SoniVie is developing the TIVUS System for various hypertensive disorders, including resistant hypertension, pulmonary hypertension, and chronic obstructive pulmonary disease with chronic bronchitis. The company’s offices are located in Rehovot, Israel, and Minneapolis, MN, USA.

Expanding Applications and Market Trends in Renal Denervation

SoniVie is advancing its technology beyond renal artery denervation for resistant hypertension. The company is developing programs for pulmonary artery denervation targeting pulmonary hypertension and total lung denervation for chronic obstructive pulmonary disease with chronic bronchitis. Further, in December 2023, Ablative, based in the US, announced that its Peregrine System Kit for alcohol-mediated renal denervation achieved the primary endpoint in a Phase III trial. According to a GlobalData report, the renal denervation catheter market is set to reach $533 million by 2033, reflecting a compound annual growth rate (CAGR) of 26% from 2023.

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Author

Bernice Lottering